NCT03592368

Hostile Interpretation Bias Training to Treat Irritability

Neurocognitive Targets of Hostile Interpretation Bias Training to Treat Irritability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability.

Detailed description

This trial lays the foundation for a preliminary test of efficacy of IBT on irritability by establishing IBT's neurocognitive treatment targets: hostile interpretation bias and response in the neural threat-learning system. The design is a single-blinded, randomized controlled trial of IBT on its targets. The study will have four arms, with 25 participants in each arm for all four conditions of training (active versus sham) and scanning (in MRI or out of MRI scanner). During IBT, participants judge as happy or angry facial expressions which are on a continuum between happy and angry. The point at which judgments shift from predominantly happy to angry on this continuum is the indifference point. During training feedback encourages no change in the indifference point or a change in the indifference point towards more happy judgments of ambiguous faces. A shift in indifference point towards more benign judgments is interpreted as a reduction in hostile interpretation. The design will test whether active relative to sham IBT shifts the indifference point towards more benign judgments. Neural response to active versus sham IBT will be measured in half the sample.

Conditions

• Irritable Mood
• Mood Disorders

Interventions

Type	Name	Description
DEVICE	IBT	Interpretation bias training

Timeline

• Start date: 2018-10-15
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2018-07-19
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study